Thin Gingival PhenotypeNCT07879534
Injectable Platelet-Rich Fibrin Versus Hyaluronic Acid for Thin Gingival Phenotype
A study testing Injectable Platelet Rich Fibrin and Hyaluronic Acid in people with Thin Gingival Phenotype, run by University of Yaounde 1 at 1 site in Cameroon.
Trial summary
Thin gingival phenotype may increase susceptibility to soft-tissue complications in the presence of local anatomical or mechanical risk factors. Minimally invasive injectable approaches such as injectable platelet-rich fibrin (i-PRF) and hyaluronic acid (HA) have been proposed to increase gingival thickness. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Thin Gingival Phenotype
- What is being tested?
- Injectable Platelet Rich Fibrin and Hyaluronic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCameroon
- Study dates
- 10 Jun 2024to 31 Aug 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Systemically healthy adults aged 18 to 40 years
- Non-smokers
- Good oral hygiene with plaque index below 15%
- Bilateral thin gingival phenotype in the mandibular anterior region
- Thin gingival phenotype confirmed by visibility of a periodontal probe through the gingival tissue
- Presence of the six mandibular anterior teeth required for split-mouth evaluation
- Willingness to participate and provision of written informed consent
Who cannot join
- Periodontal probing depth greater than 3 mm in the study region
- Severe bleeding on probing or active periodontal inflammation
- Previous mucogingival or periodontal surgery in the mandibular anterior region
- Ongoing orthodontic treatment
- Pregnancy or breastfeeding
- Coagulation or platelet disorders
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- Use of medications known to affect gingival morphology or periodontal tissues
- Tooth mobility in the study region
- Missing or supernumerary teeth in the mandibular anterior study region
Trial locations and contacts
1 site in 1 country.
Cameroon1 site
Faculty of Medicine and Biomedical Sciences, University of Yaounde I
Yaoundé
About this study
Official title: Comparative Efficacy of Injectable Platelet-Rich Fibrin Versus Hyaluronic Acid for Gingival Phenotype Modification: A Randomized Split-Mouth Clinical Trial
Thin gingival phenotype may increase susceptibility to soft-tissue complications in the presence of local anatomical or mechanical risk factors. Minimally invasive injectable approaches such as injectable platelet-rich fibrin (i-PRF) and hyaluronic acid (HA) have been proposed to increase gingival thickness. This randomized split-mouth clinical trial compared repeated i-PRF and non-cross-linked HA injections in adults with a thin mandibular anterior gingival phenotype. Each participant received i-PRF on one mandibular anterior hemi-arch and HA on the contralateral hemi-arch. The primary objective was to compare changes in gingival thickness and keratinized tissue width between the two interventions. Periodontal clinical parameters and injection-related morbidity were assessed as secondary outcomes.
Read the detailed description
Eleven systemically healthy adults with bilateral thin gingival phenotype in the mandibular anterior region were enrolled. A computer-generated random sequence assigned the left or right mandibular anterior hemi-arch to i-PRF; the contralateral side received non-cross-linked sodium hyaluronate. Allocation was concealed using sealed opaque envelopes. Participants were masked to side allocation; the clinical operator who prepared and administered the interventions and performed outcome measurements was aware of allocation. Both interventions were delivered during the same treatment sessions in a within-participant split-mouth design, with three injection sessions at 7-day intervals (Day 0, Day 7, and Day 14). Gingival thickness and keratinized tissue width were assessed at baseline, 30 days after the third injection, and 2 months after the first follow-up.
- Conditions
- Thin Gingival Phenotype
- Being tested
- Injectable Platelet Rich Fibrin, Hyaluronic Acid
- Keywords
- gingival phenotype, injectable platelet-rich fibrin, hyaluronic acid, split-mouth trial, periodontology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable Platelet Rich FibrinBiological
Also called i-PRF
At each session, 10 mL of venous blood was collected into an anticoagulant-free tube and immediately centrifuged using a DUO Quattro centrifuge (Process for PRF, Nice, France) at 700 rpm (approximately 60 x g at the maximum rotor radius). Centrifugation was performed for 5 minutes in female participants and 6 minutes in male participants, according to the protocol used in the study. The upper orange liquid fraction was collected. Using 1-mL insulin syringes with integrated 30-gauge needles, i-PRF was slowly injected at two points per treated tooth: approximately 3 mm apical to the free gingival margin and apical to the mucogingival junction. Injection continued until visible tissue blanching; no predetermined fixed volume was administered per injection point or tooth. Three sessions were performed on Day 0, Day 7, and Day 14.
Hyaluronic AcidDrug
Also called ADANT, Sodium hyaluronate
Non-cross-linked sodium hyaluronate (ADANT, 10 mg/mL; 2.5-mL prefilled syringe) was used. Using 1-mL insulin syringes with integrated 30-gauge needles, hyaluronic acid was slowly injected at two points per treated tooth: approximately 3 mm apical to the free gingival margin and apical to the mucogingival junction. Injection continued until visible tissue blanching; no predetermined fixed volume was administered per injection point or tooth. Three sessions were performed on Day 0, Day 7, and Day 14.
| Study group | Role | What they receive |
|---|---|---|
| Injectable Platelet Rich Fibrin | Experimental | One randomly allocated mandibular anterior hemi-arch received injectable platelet-rich fibrin at three weekly injection sessions. Receives: Biological: Injectable Platelet Rich Fibrin |
| Hyaluronic Acid | Active comparator | The contralateral mandibular anterior hemi-arch received non-cross-linked sodium hyaluronate (ADANT) at the same three weekly injection sessions. Receives: Drug: Hyaluronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Thickness (GT)
Gingival thickness measured in millimeters by standardized transgingival probing and digital caliper.
Measured: Baseline; 30 days after the third injection; 2 months after the first follow-up
Keratinized Tissue Width (KTW)
Keratinized tissue width measured in millimeters from the free gingival margin to the mucogingival junction.
Measured: Baseline; 30 days after the third injection; 2 months after the first follow-up
Secondary outcomes (6)
Gingival Inflammation
Gingival inflammation assessed using a 0 to 3 ordinal gingival index.
Measured: Baseline; 30 days after the third injection; 2 months after the first follow-up
Bleeding on Probing
Bleeding on probing assessed using the study 0 to 5 ordinal bleeding severity scale.
Measured: Baseline; 30 days after the third injection; 2 months after the first follow-up
Probing Depth Category
Probing depth recorded as an ordinal category: less than 3 mm, 3 to 5 mm, or greater than 5 mm.
Measured: Baseline; 30 days after the third injection; 2 months after the first follow-up
Injection-Related Pain
Pain assessed on a four-grade verbal scale: absent, mild, moderate, or severe.
Measured: Day 0; Day 7; Day 14
Injection-Related Edema
Edema assessed on a four-grade verbal scale: absent, mild, moderate, or severe.
Measured: Day 0; Day 7; Day 14
Postoperative Bleeding
Postoperative bleeding assessed on a four-grade verbal scale: absent, mild, moderate, or severe.
Measured: Day 0; Day 7; Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start10 Jun 2024
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thin Gingival PhenotypeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized split-mouth (within-participant) parallel design. Each participant received both interventions concurrently at different intra-oral sites: i-PRF on one mandibular anterior hemi-arch and HA on the contralateral hemi-arch. The intervention side was determined by randomization; there was no time-based treatment sequence or washout period.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Yaounde 1
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ndjoh Jules Julien, University of Yaounde 1
- Investigators
- Jules Julien Ndjoh, Principal investigator, Department of Implantology-Periodontology-Prosthodontics, Faculty of Medicine and Biomedical Sciences, University of Yaounde I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879534
- Sponsor's protocol ID
- FMSB-UY1-IPRFHA-2024-02
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in this trial, including gingival thickness, keratinized tissue width, periodontal clinical parameters, and injection-related morbidity data, will be available upon reasonable request to the corresponding author.